Insmed Launches Pivotal Phase III Clinical Trial in GHIS
Monday June 23, 9:15 am ET
Data Analysis Planned for Early 2004
RICHMOND, Va.--(BUSINESS WIRE)--June 23, 2003--Insmed Incorporated (Nasdaq: INSM - News) announced today the initiation of a pivotal Phase III clinical trial with rhIGF-I/rhIGFBP-3 in children with growth hormone insensitivity syndrome (GHIS).
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The pivotal Phase III study with rhIGF-I/rhIGFBP-3 in children with GHIS is designed to measure an increase in linear growth velocity, with a 6-month primary endpoint analysis planned for early 2004. Data generated from this trial combined with data from Pharmacia's extensive GHIS European regulatory filings acquired in the fall of 2002 will be used to support marketing applications in 2004.
Geoffrey Allan, Ph.D., president and chief executive officer of Insmed, commented, "This marks a critical milestone in the transformation of Insmed to a commercially-focused organization. An approval in GHIS will set the stage for other markets where IGF-I therapy may be indicated. Given the serious nature of low IGF-I levels for the developing body, we will continue to work diligently to make this therapy available to meet this important unmet medical need."
Insmed recently announced that the EMEA has granted the company orphan drug designation for rhIGF-I/rhIGFBP-3 in GHIS, which provides the company with 10 years of market exclusivity in Europe upon approval. Last year, the FDA granted orphan drug designation to the company for rhIGF-I/rhIGFBP-3 in GHIS, which provides the company seven years of market exclusivity in the United States upon approval.
GHIS is a rare genetic condition in which patients, when exposed to growth hormone (GH), do not generate insulin-like growth factor-I, the mediator of many of the effects ascribed to GH. IGF-I is essential for proper growth and metabolism. Children with GHIS do not recognize or respond to human growth hormone and as a result fail to produce physiologically relevant levels of IGF-I. The normalization of IGF-I levels has been shown to significantly increase growth in GHIS patients.
Corporate Presentation to be Webcast Live Today at 11:15 a.m. Eastern Time
Insmed Incorporated has been selected to present to the Biotechnology Industry Organization Annual Convention, BIO 2003, to take place June 22-25 at the Washington Convention Center, Washington, D.C. The presentation will take place today at 11:15 a.m. Eastern Time. |
